Utility of Restrata With Split-thickness Skin Graft to Reconstruct the Forearm Donor Site

Head and Neck Cancer Clinical Trial

Official title:

Utility of Restrata With Split-thickness Skin Graft to Reconstruct the Forearm Donor Site

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04880603
• Other study ID #: Restrata
• Status: Terminated
• Phase: Phase 2
• Start date: April 5, 2021
• Est. completion date: April 25, 2022

Study information

• Verified date: May 2022
• Source: Nebraska Methodist Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Adult patients undergoing a radial forearm free flap or ulnar forearm free flap will be randomized to the use of the Restrata graft in combination with split-thickness skin graft for reconstruction. Photos will document whether the Restata graft aids in the healing.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: April 25, 2022
• Est. primary completion date: April 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• All patients age 19 or greater that will undergo radial forearm free flap or ulnar free flap.

• Photo documentation of wound bed at two weeks and four weeks must be obtainable either by physician or patient.

Exclusion Criteria:

• Active systemic immunosuppression (active use of high-dose steroids (=40mg prednisone daily or equivalent) or other immunosuppressive medications OR medical conditions causing immunosuppression, i.e. human immunodeficiency virus etc).

• Diabetes mellitus with most recent Hemoglobin A1c =10.0 within 30 days prior to surgery.

• Morbid obesity (BMI >40).

• Inability to maintain wrist immobilization for full planned period.

• Severe malnutrition (prealbumin levels <10 mg per dL within 30 days prior to surgery OR BMI <15 (very severely underweight).

• Other conditions felt to significantly impair wound healing per surgeon discretion

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Device:
• Restrata Graft
Restrata will be meshed in a 1:2 fashion to allow for egress of serous fluid and minimize risk of fluid collection. Restrata will be applied to the entire wound bed not amenable to primary closure and will be underlaid beneath the surrounding skin edges. A split-thickness skin graft is harvested from patient's thigh at 15:1000 inches and placed on top of the Restrata to cover the entire wound bed. The graft is sutured in place using suture choice of surgeon's preference.

Procedure:
• Standard of Care Skin Graft
Standard of Care Skin Graft

Locations

Country	Name	City	State
United States	Nebraska Methodist Hospital	Omaha	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
Nebraska Methodist Health System	Acera Surgical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tendon exposure	Tendon exposure at four weeks post-operatively (Yes/No).	4 weeks post-operation
Primary	Percentage of surface area	Percentage of surface area of split-thickness skin graft incorporation at four weeks postoperatively.	4 weeks post operation